TREg Activation in the Treatment of the PELADE (Alopecia Areata)
- Registration Number
- NCT02557074
- Lead Sponsor
- Centre Hospitalier Universitaire de Nice
- Brief Summary
In a prospective pilot study the investigators showed that low doses of IL2 could be beneficial for severe AA inducing a long lasting regrowth in 4 out of the 5 patients treated.
The objective of this study is to compare the long term efficacy of low doses of IL2 versus placebo in a multicenter prospective randomized double blind study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- Of more than 18 years old,
- Affiliated to the social security system,
- Clinical diagnosis of alopecia areata,
- 50 % of the surface of the scalp affected
- Last flaire started less than one year
- Alopecia areata resisting to at least 1 systematic treatment including phototherapy (UVB or PUVA), general corticosteroid therapy or methotrexate
- Signature of the informed consent
- Pregnancy or refusal of contraception at the women old enough to procreate,
- Refusal of contraception at the men
- Local treatment (dermocortico茂des, minoxidil) or systematism (oral corticosteroid therapy, m茅thotrexate or the other immunosuppresseur) since less than 2 less,
- Evolutionary autoimmune cancer or disease or in forgiveness
- Excessive grip(taking) of alcohol (upper to 3 glasses of wine a day or one pre-lunch drink a day)
- Seropositivity VHC, VHB, or HIV
- Patient presenting a severe renal and/or hepatic insufficiency,
- Presenting patient one zoned, the chicken pox, the herpes, the tuberculosis, an evolutionary infectious disease, a respiratory failure ...
- Vulnerable person (nobody under guardianship minor(miner), adults, deprived of freedom)
- IC in the treatment(processing) by IL-2R
- Presenting a contraindication to ProleukinR
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo - Group B placebo NaCl 9% serum (placebo) NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment IL2 - Group A IL2 Patient will received IL2 low doses (1.5 to 3MUI/d) - * IL2 1.5MUI/d SC from day 1 to day 5 for the first course of treatment * IL2 3MUI/d SC from day 1 to day 5 for the 3 following courses
- Primary Outcome Measures
Name Time Method Score Salt Once : at 12 months post-treatment Success defined by a SALT score lower or equal to 25 at the end the study (12 months post-treatment). It will be calculated by 2 physicians blinded to the treatment received on standardized pictures.
- Secondary Outcome Measures
Name Time Method Quality of life at one day, 22 days, 43 days, 64 days, 251 days, 434 days The quality of life (QdV) will be estimated with the scale DLQI which is a scale of QdV validated for the dermatological diseases.
Adverse Event at one day, 22 days, 43 days, 64 days, 251 days, 434 days The tolerance will be clinically and biologically estimated at each visit. The type and the rank of every AE will be raised.
Satisfaction of patient at 12 months post-treatment The satisfaction of the patients will be estimated on an analog visual scale(ladder) going of 0 (not satisfied) to 10 (very satisfied).
Trial Locations
- Locations (6)
AP-HM - La timone - Dermatologie
馃嚝馃嚪Marseille, Bouche Du Rh么ne, France
CHU de Nimes - Dermatologie
馃嚝馃嚪N卯mes, Languedoc-Roussillon, France
CHI St Raphael Fr茅jus - Dermatologie
馃嚝馃嚪Fr茅jus, Paca, France
CHU Montpellier - Dermatologie
馃嚝馃嚪Montpellier, France
CHU de Nice - dermatologie
馃嚝馃嚪Nice, France
AP-HP St Louis - Dermatologie
馃嚝馃嚪Paris, Ile De France, France